NX SYSTEM


Device Classification Name

transmitters and receivers, physiological signal, radiofrequency

510(k) Number K030222
Device Name NX SYSTEM
Original Applicant
AMERICAN TELECARE, INC.
7640 golden triangle dr.
eden prairie, 
MN 
55344 -3732

Original Contact pete plucinak
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 01/22/2003
Decision Date 08/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No